Key result
New oral anticoagulants were more effective and safer than vitamin K antagonists across subgroups, though bleeding risk reduction was significantly greater in patients with a CHADS2 score of 0-1 (RR 0.67) than those with a score >=2 (RR 0.85).
Why the study?
Do new oral anticoagulants (NOACs) reduce stroke, systemic embolism, and major bleeding compared to vitamin K antagonists across different subgroups of patients with non-valvular atrial fibrillation?
Meta-Analysis (n=50,578)
Double-blind and Open-label
Randomized
Yes
Do new oral anticoagulants (NOACs) reduce stroke, systemic embolism, and major bleeding compared to vitamin K antagonists across different subgroups of patients with non-valvular atrial fibrillation?
NOACs provide consistent reductions in stroke, systemic embolism, and major bleeding compared to VKAs across various patient subgroups with non-valvular atrial fibrillation, though the magnitude of bleeding reduction is greater in patients with lower CHADS2 scores.
Answers are grounded in this paper and cite their sources.
Supports NOAC preference over VKAs in non-valvular AF, especially for bleeding reduction in low CHADS2; extends subgroup evidence from prior trials.
AIMS: The well-known limitations of vitamin K antagonists (VKA) led to development of new oral anticoagulants (NOAC) in non-valvular atrial fibrillation (NVAF). The aim of this meta-analysis was to determine the consistency of treatment effects of NOAC irrespective of age, comorbidities, or prior VKA exposure. METHODS AND RESULTS: All randomized, controlled phase III trials comparing NOAC to VKA up to October 2012 were eligible provided their results (stroke/systemic embolism (SSE) and major bleeding (MB)) were reported according to age (≤ or >75 years), renal function, CHADS2 score, presence of diabetes mellitus or heart failure, prior VKA use or previous cerebrovascular events. Interactions were considered significant at p <0.05. Three studies (50,578 patients) were included, respectively evaluating apixaban, rivaroxaban, and dabigatran versus warfarin. A trend towards interaction with heart failure (p = 0.08) was observed with respect to SSE reduction, this being greater in patients not presenting heart failure (RR = 0.76 [0.67-0.86]) than in those with heart failure (RR = 0.90 [0.78-1.04]); Significant interaction (p = 0.01) with CHADS2 score was observed, NOAC achieving a greater reduction in bleeding risk in patients with a score of 0-1 (RR 0.67 CI 0.57-0.79) than in those with a score ≥2 (RR 0.85 CI 0.74-0.98). Comparison of MB in patients with (RR 0.97 CI 0.79-1.18) and without (RR 0.76 CI 0.65-0.88) diabetes mellitus showed a similar trend (p = 0.06). No other interactions were found. All subgroups derived benefit from NOA in terms of SSE or MB reduction. CONCLUSIONS: NOAC appeared to be more effective and safer than VKA in reducing SSE or MB irrespective of patient comorbidities. Thromboembolism risk, evaluated by CHADS2 score and, to a lesser extent, diabetes mellitus modified the treatment effects of NOAC without complete loss of benefit with respect to MB reduction.
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Lega et al. (2014) conducted a meta-analysis in Non-valvular atrial fibrillation (n=50,578). New oral anticoagulants (apixaban, rivaroxaban, dabigatran) vs. Vitamin K antagonists (warfarin) was evaluated on Major bleeding in patients with CHADS2 score 0-1 (RR 0.67, 95% CI 0.57-0.79, p=0.01). New oral anticoagulants were more effective and safer than vitamin K antagonists across subgroups, though bleeding risk reduction was significantly greater in patients with a CHADS2 score of 0-1 (RR 0.67) than those with a score >=2 (RR 0.85).
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